User Fee Forecast For May: Approvals Could Sprout In Multiple Divisions
Executive Summary
Aimovig, Andexxa, Lucemyra, and pegvaliase are among the almost 20 products with upcoming user fee goals at US FDA this month.
You may also be interested in...
As Amgen Looks To Aimovig's Launch, It May Learn From Repatha's Past
Amgen started 2018 off on solid footing with a 2% jump in Q1 revenue to $5.55bn versus consensus estimates of $5.4bn, but new drugs like the CGRP inhibitor Aimovig are needed to keep the momentum going and supplement declining sales for key products.
Lofexidine Gets US FDA Panel Nod For Mitigating Opioid Withdrawal Symptoms
But Psychopharmacologic Drugs Advisory Committee says US WorldMeds' second proposed indication for facilitating completion of opioid discontinuation treatment is not supported by data from two short-term studies in an 'idealized' population.
Portola May Need Randomized Trial For AndexXa Approval. The Question Is When
Randomized trial represents higher bar for US approval of reversal agents for novel anticoagulants than expected – and if needed prior to approval, could delay AndexXa launch for two or maybe even four years.